A Real-world Study of Asciminib Effectiveness in Philadelphia Positive Acute Lymphoblastic Leukem… (NCT07644351) | Clinical Trial Compass
CompletedNot Applicable
A Real-world Study of Asciminib Effectiveness in Philadelphia Positive Acute Lymphoblastic Leukemia Patients
United States, Australia, Canada37 participantsStarted 2024-12-16
Plain-language summary
The aim of this study was to collect existing information from the medical charts of patients enrolled in the ongoing asciminib Managed Access Program (MAP) to better understand the effectiveness and safety of asciminib when used to treat adult patients with Ph+ ALL who are refractory, resistant or intolerant to available treatments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Adult patients enrolled in the asciminib MAP.
* Diagnosis of Ph+ ALL.
* Patients received at least one dose of asciminib through the asciminib MAP.
* Appropriate approval obtained for the use of patient data including:
* Signed informed consent form (ICF), or
* ICF waiver granted by an Institutional review board/Independent Ethics Committee (IRB/IEC).
Exclusion criteria
• Age \< 18 years at the time of initiating asciminib treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a completed real-world study of asciminib in Philadelphia chromosome-positive ALL, has the data been published yet, and what did it show about how many patients achieved complete remission within the first three months?
2Asciminib was studied here as a real-world treatment rather than in a controlled clinical trial — does that change how confident you are in applying these results to my specific situation?
3The study measured complete remission and CRi within the first three months, but what happens after that window — is there data on how durable those remissions were, and does asciminib remain an option if remission isn't achieved in that timeframe?
4Given that my leukemia is Philadelphia chromosome-positive, how does asciminib compare to other BCR-ABL targeted therapies I might already be considering, and would you recommend it as part of my frontline treatment or in a later line?
5Are there specific patient characteristics from this real-world study — such as age, prior treatments, or mutation profile — that would help us understand whether the results might be relevant to my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients Achieving Hematological Complete Remission (CR) or Hematological Complete Remission With Incomplete Count Recovery (CRi) in the First 3 Months of Treatment